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Calcium Borogluconate Livestock

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Calcium Borogluconate Livestock Calcium Borogluconate Livestock Identification Chemical Name: CAS Number: D-gluconic acid cyclic 4,5 ester with boric acid 5743-34-0 calcium salt Other Names: Other Codes: none found Cal Aqua, Cal-Nate 1069, Cal-MPK, Cal-MP 1700, Calciphos, calcium gluconate, and others Summary Recommendation Synthetic / Allowed or Suggested Non-Synthetic: Prohibited: Annotation: Synthetic Allowed (consensus) Preventive measures and use of non-synthetic alternatives must be documented (consensus) in the Farm Plan. (consensus) Characterization Composition: C12H20B2CaO16 Properties: Crystals, freely soluble in water. Solubility in water of 1:1 at 15°C., 2.8:1 at 100°C. Acidic: a 20% aqueous solution has a pH of 3.5 (Budavari, 1996). How Made: Calcium borogluconate is prepared by the reaction of five parts calcium gluconate to one part boric acid in an aqueous solution (MacPherson and Stewart, 1938). In Orlando in 1995, the NOSB considered boric acid in a separate TAP review for crop use and voted it to be synthetic and allowed. Annotation is “May be used for structural pest contol. No direct contact with food or crops being certified.” Calcium gluconate is prepared by a number of methods, including the reaction of gluconic acid with calcium hydroxide. Calcium hydroxide was also reviewed by the NOSB for processing at the Orlando meeting and was voted synthetic and allowed. Gluconic acid may be synthesized (Budavari, 1996). However, it is most commonly produced in the U.S. by fermentation (Sergha, 1994). The organism responsible for fermentation is Aspergillus niger. Genetic engineering to improve production of gluconic acid has been the subject of research, but it is not clear if gluconic acid is now produced by GMOs (Nagarajan, 1994). Specific Uses: Calcium borogluconate is for treatment of hypocalcemia (also called parturient paresis and commonly called milk fever) in cattle, sheep, and goats, and administered at 1 ml/kg ( intravenous, intramuscular, or subcutaneous). No withdrawal time is required (Allen, et al, 1993). Milk fever is the result of metabolic stress occurring only at or near parturition (giving birth). The mother mobilizes large amounts of calcium to produce milk to feed newborn, and blood calcium levels can drop below the point necessary for impulse transmission along the nerve tracts (Herren & Donahue, 1991). The disease may occur in cows of any age but is most common in high-producing dairy cows more than five years old (Aiello, 1998). There are three discernable stages of milk fever for cows: in stage one, cows are able to stand but show signs of hypersensitivity and excitability. In stage two, cows are unable to stand. In stage three, cows lose consciousness progressively to the point of coma. Cows in stage three may survive only a few hours (Aiello, 1998). Formulations may be labeled “calcium gluconate” but the active ingredient, in many cases, is listed as calcium borogluconate. Last Updated 3 November, 2000 NOSB TAP Materials Database Compiled by OMRI Page 1 of 8 NOSB TAP Review Compiled by OMRI Calcium Borogluconate Livestock Action: Calcium borogluconate raises the calcium level in the blood. No natural calcium sources to do this were suggested in the literature reviewed. Feeding natural calcium sources in stages two and three may not be possible due to the severe illness milk fever causes (Hoard’s Dairyman, 1993). Combinations: Calcium borogluconate can be combined with phosphorus, potassium, and magnesium and is sometimes administered with an analgesic or local anesthetic. It can also be mixed with calcium oxide, formaldehyde, or dextrose. It usually comes in a 23% solution, equivalent to 19.78 mg/ml calcium (Allen, 1993). Status OFPA Falls under “livestock medicines” in 7 USC 6517(c)(1)(B)(i). Regulatory Listed as an animal drug under 21 CFR sections 150.141, 150.161, and 184.199 (calcium gluconate). Status among U.S. Certifiers Generally allowed to treat ill animals. Historic Use The first use to treat hypocalcemia in cattle was reported in 1934 (Hayden) and confirmed in 1935 (Dryerre and Grieg; both reported in MacPherson and Stewart, 1938). It is commonly the preferred treatment for milk fever by dairy farmers since then, although Hoard’s Dairyman lists calcium gluconate as the method of choice. In a 1990 survey, more than 82% of Hoard’s Dairyman readers reported milk fever in their herds, with over eight percent of the cows affected (1993). International Codex Alimentarius allows chemical allopathic veterinary drugs or antibiotics to be used “under the responsibility of a veterinarian” if the use of alternative methods are “unlikely to be effective in combating illness or injury.” Withholding periods are required to be double of those required by law with a minimum of 48 hours (Codex, 2000). The European Union has a similar standard (EC 1999). IFOAM allows conventional medicines “when no other justifiable alternative is available” (IFOAM, 2000). Section 2119 OFPA 7 U.S.C. 6518(m)(1-7) Criteria 1. The potential of the substance for detrimental chemical interactions with other materials used in organic farming systems. Calcium interacts with phosphorous and vitamin D in the diets of dairy cattle (NRC, 1989) and other mammals. The interaction may be detrimental pre-parturition, but animals are treated at parturition (Aiello, 1998). Other cations, especially magnesium, may be antagonistic (Allen et al., 1993). It is also incompatible with sodium bicarbonate (Allen et al., 1993). Injections of calcium borogluconate and lidocaine have been linked to false positives of antibiotics in slaughter animals (Nouws, 1975). 2. The toxicity and mode of action of the substance and of its breakdown products or any contaminants, and their persistence and areas of concentration in the environment. Calcium infusion is associated with lowering blood pH, respiratory acidosis, and heart attacks (Allen, 1993; Farningham, 1985; and Fenwick, 1994). To avoid heart attack or arrhythmias, intravenous injection of calcium borogluconate should be given slowly. For effectiveness, the injection should be heated to blood temperature and administered as soon as the hypocalcemia is detected (Fenwich, 1994). 3. The probability of environmental contamination during manufacture, use, misuse, or disposal of such substance. The fermentation step in the process may involve a genetically engineered strain of A. niger, but otherwise has the same environmental impacts of fermentation processes in general. The boric acid and calcium hydroxide steps in the process were considered in previous TAP reviews. 4. The effects of the substance on human health. The substance is used to treat humans for hypocalcemia as well; calcium chloride is the treatment of choice in humans (White et al., 1976). Dairy animals may be treated without any withdrawal period (product label). There is no Last Updated 3 November 2000 Page 2 of 8 NOSB TAP Review Compiled by OMRI Calcium Borogluconate Livestock listing on the National Toxicology Program Database or the Food Animal Residue Avoidance Database as of October 5, 2000. 5. The effects of the substance on biological and chemical interactions in the agroecosystem, including the physiological effects of the substance on soil organisms (including the salt index and solubility of the soil), crops, and livestock. Calcium borogluconate is preferred to calcium gluconate because it is more soluble (Budavari, 1996). Rapid administration and high concentrations may cause heart blockage (Allen et al., 1993). The material is metabolized by the animal, with the calcium entering the blood stream and some being expressed as milk. The animal’s urine and feces may contain higher levels of boron as a result, but none of the literature reviewed partitioned the fate. Some claim that introduction of boron and sugar is either unnecessary or causes complications, but these are not specified (Carnes et al., 1980). 6. The alternatives to using the substance in terms of practices or other available materials. Proper nutrition is the most effective alternative. Although high calcium in dry cows accentuates milk fever, high calcium intake at calving can reduce its incidence. Maintaining calcium, phosphorous, and Vitamin D levels in their proper ranges for dry cows and at calving can prevent milk fever (NRC, 1989). Cations other than calcium may play an important role in prevention. Data from 75 published trials suggested that the correlation between milk fever and the anion-cation balance (ACB or DCAB) was stronger than that for calcium levels (Oetzl, 1991). This has been further tested in experiments using potassium and sodium without calcium supplementation (Goff and Horst, 1997). Other prevention strategies are breeding for less milk production, access to pasture, reducing stress prior to parturition, and feeding strategies. Culling milk fever-susceptible cows may be a desirable strategy because milk fever is correlated positively with other disorders, such as dystocia (difficult birth), retained placenta, and metritis (uterine infection) (Erb et al., 1985). Preventative rations may have slightly lower calcium levels and higher phosphorus levels just before parturition and then increased calcium levels after parturition; such rations may result in dangerous depletion of skeletal mineral reserves if continued for long periods in heavy-milking cows (Aiello, 1998). Also, feeding Vitamin D3 helps stimulate the body to absorb calcium (NRC, 1989). Feeding synthetic bovine parathyroid hormone (PTH) is also a preventative measure. Increasing the amount of
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